phase 2 randomized clinical trial of luminate® as compared to avastin® in the treatment of diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: a phase 2 multi center, randomized, controlled, double-masked clinical trial designed to evaluate the safety and exploratory efficacy of luminate® (alg-1001) as compared to avastin® in the treatment of diabetic macular edema

to evaluate the safety and efficacy of luminate® (alg-1001) as compared to avastin® in patients with diabetic macular edema - stage 1: 120 eligible subjects with dme will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of luminate intravitreal injection or avastin intravitreal injection. subjects will be followed monthly for 24 weeks (6 months). stage 2 (select sites): 75 eligible subjects with dme will be enrolled and randomized to one of 5 treatment groups at an allocation ratio of 1:1:1:1:1; i.e., one of 2 doses of luminate intravitreal injection or avastin intravitreal injection (0.5 mg and 1.0 mg). subjects will be followed monthly for 20 weeks (5 months).

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older. * study eye with clinically significant diabetic macular edema (dme) with central subfield thickness ≥ 350µm on spectral domain oct * best corrected visual acuity (bcva) of 20/50 to 20/320 etdrs equivalent (65 letters to 23 letters) in the study eye, with bcva decrement primarily attributable to dme. * treatment naïve, i.e., no previous anti-vegf treatment in the study eye or no anti-vegf treatment in the 45 days prior to study enrollment. * in the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and bcva. * intra-ocular pressure (iop) is under control (i.e., iop ≤ 25 mm in the study eye) and study eye is not receiving any iop lowering drops. * willing and able to return for all study visits. * able to meet the extensive post-op evaluation regimen. * understands and signs the informed consent form. exclusion criteria: * active proliferative diabetic retinopathy (pdr) in the study eye such as nve, nvd, vitreous hemorrhage, or neovascular glaucoma. * uncontrolled hypertension defined as systolic \>180 mmhg or \> 160 mmhg on 2 consecutive measurements or diastolic \> 100 mmhg on optimal medical regimen * screening hga1c blood test \> 10.0 * focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment. * a history of intravitreal anti-vegf injection of any type in the study eye within the last 45 days prior to study enrollment. * history of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye. * epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center. * previous pars plana vitrectomy in the study eye * any intraocular surgery in the study eye within the last 90 days prior to study enrollment. * yag laser treatment in the study eye in last 30 days prior to study enrollment. * high myopia in the study eye, with a spherical equivalent of \>8.00d at screening * other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye. * chronic or recurrent uveitis. * ongoing ocular infection or inflammation in either eye. * a history of cataract surgery complications/vitreous loss in the study eye. * congenital eye malformations in the study eye. * a history of penetrating ocular trauma in the study eye. * mentally handicapped. * pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window. * nursing female. * currently participating in any other clinical research study. * contraindication to the study medication.